[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,404,0,25,[9,47,69,96,125,149,174,197,229,255,290,320,350,379,408,436,512,531,556,576,627,653,674,700,723],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053511","chaamp-charlotte-advocate-mgus-project-internal-pilot-study-100053511",false,"NCT06644625","CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study","SCREENING Inclusion Criteria:\n\n* Age 30 years or older at the time of consent\n* Either:\n\n  1. Self-identify as Black and\u002For African American OR\n  2. First-degree relatives (parents, siblings, or children) of patients of any race or ethnicity diagnosed with a plasma cell disorder, including MGUS, smoldering multiple myeloma (SMM), multiple myeloma (MM), solitary plasmacytoma, plasma cell leukemia, AL amyloidosis, POEMS syndrome, and Waldenström's Macroglobulinemia\n* Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately\n* Reside in Charlotte, NC, or the surrounding area, based on self-report\n\nSCREENING Exclusion Criteria:\n\n* Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.\n\nLONGITUDINAL Inclusion Criteria:\n\n* Test positive for monoclonal gammopathy during screening portion of the study\n* Consent to the longitudinal portion of the study\n\nLONGITUDINAL Exclusion Criteria:\n\n* The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.",true,"ALL","30 Years",{"count":20,"type":21},1665,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.",[25,26,27,28,29],"Multiple Myeloma","Multiple Myeloma Progression","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)","Plasma Cell Disorders",[31,32,33],"multiple myeloma","hematology","plasma cell disorders","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-03-01",{"date":42,"type":21},"2035-01",{"name":44,"class":45},"Wake Forest University Health Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":22,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":46},"100054080","myeloma-registry-platform-myriam-100054080","NCT03308474","Myeloma Registry Platform (MYRIAM)","Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)","MYRIAM","Inclusion Criteria:\n\n* MM requiring systemic (first-, second- or third-line) treatment (closed for first-line \u002F second-line recruitment)\n* Age ≥ 18 years\n* Written informed consent\n\n  * Patients participating in the PRO satellite: signing of informed consent and completion of baseline questionnaire before, but not more than eight weeks before the start of respective systemic treatment\n  * Patients not participating in the PRO satellite: signing of informed consent not later than four weeks after start of respective treatment, and not more than eight weeks before the start of respective systemic treatment\n* Sufficient German language skills for participation in the PRO satellite\n\nExclusion Criteria:\n\n* No systemic therapy for myeloma\n* Patients already enrolled in studies that prohibit any participation in other studies","18 Years",{"count":57,"type":21},2200,"5 Years","The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Multiple Myeloma in Germany.",[25],{"date":37,"type":38},{"date":63,"type":38},"2017-09-25",{"date":65,"type":21},"2028-12",{"name":67,"class":68},"iOMEDICO AG","INDUSTRY",{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":16,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},"100053329","pre-malignant-states-to-hematologic-malignancies-in-firefighters-100053329","NCT06870760","Pre-malignant States to Hematologic Malignancies in Firefighters","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 40-49 years at the time of consent (self-reported)\n3. Ability of the participant to understand and comply with study procedures for the entire length of the study\n4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)\n\nExclusion Criteria:\n\nAnyone with a current diagnosis of a hematologic malignancy will be excluded.","40 Years","49 Years",{"count":78,"type":21},300,"The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.",[81,82,83,84,25,85],"Clonal Hematopoiesis of Indeterminate Potential","Monoclonal Gammopathy","Non Hodgkin Lymphoma","Leukemia","Plasma Cell Disorder",[87,88,89],"Firefighters","CHIP","MGUS",{"date":37,"type":38},{"date":92,"type":38},"2026-06-23",{"date":94,"type":21},"2027-04",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100053571","phase-1-azd0305-as-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-multiple-myeloma-100053571","NCT06106945","AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","A Modular Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma","Key Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction\n* in which the study is taking place;\n* Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;\n* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria;\n* Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;\n* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;\n* Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy\n\nThe above is a summary of key criteria, other inclusion criteria details may apply\n\nKey Exclusion Criteria:\n\n* Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);\n* Participants exhibiting clinical signs of central nervous system involvement of MM;\n* Participants with known COPD, or previous history of ILD\u002Fpneumonitis;\n* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;\n* Participants who have severe cardiovascular disease which is not adequately controlled;\n* Participants who have a history of immunodeficiency disease;\n* Participants with peripheral neuropathy ≥ Grade 2;\n* Primary refractory MM;\n* Participants who have previously received anti-GPRC5D or MMAE-containing treatment;\n* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention;\n* Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;\n* Participants with previous history of active JC virus infection resulting in PML;\n* Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;\n* Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and\u002For other administration\n\nThe above is a summary of key criteria, other exclusion criteria details may apply",{"count":104,"type":21},226,"INTERVENTIONAL",[107,108],"PHASE1","PHASE2","This is a Phase I\u002FII, modular, open-label, multicenter, dose escalation, and dose expansion\u002Foptimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics and efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.",[25],[112,113,114,25,115,116],"GPRC5D","ADC","AZD0305","MM","MMAE",{"date":37,"type":38},{"date":119,"type":38},"2023-12-05",{"date":121,"type":21},"2027-08-16",{"name":123,"class":68},"AstraZeneca",43,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":105,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100053228","phase-1-a-phase-i-open-label-multicenter-study-to-evaluate-the-safety-tolerability-cellular-kinetics-immunogenicity-pharmacodynamics-and-preliminary-efficacy-of-azd0120-in-participants-with-multiple-myeloma-durga-2-100053228","NCT07073547","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)","A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)","Inclusion Criteria:\n\nAge:\n\n* Males and females ≥18 years of age at the time of consent\n\nType of Participant and Disease Characteristics:\n\n* Participant must have documented diagnosis of MM per IMWG diagnostic criteria\n* ECOG performance status of 0 or 1.\n* Adequate organ and bone marrow function.\n\nFor NDMM participants:\n\n* Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)\n* For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening\n* Classified as high-risk MM\n\nFor Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:\n\n* Have received and failed 1 or 2 lines of anti-myeloma therapy\n* Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy\n* Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen\n\nGeneral Exclusion Criteria:\n\n* Have received prior treatment with CAR T therapy directed at any target\n* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma\n* Active or history of plasma cell leukemia at the time of screening\n* Seropositive for human immunodeficiency virus (HIV)\n* Active Hepatitis B infection\n* Active Hepatitis C infection\n* Serious underlying medical condition",{"count":133,"type":21},40,[107],"This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).",[25],[138,139,140,141],"Multiple myeloma","BCMA","CD19","CAR-T",{"date":37,"type":38},{"date":144,"type":38},"2025-07-31",{"date":146,"type":21},"2028-05-26",{"name":123,"class":68},13,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":105,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100054075","phase-1-a-study-to-assess-adverse-events-of-intravenously-iv-infused-etentamig-abbv-383-in-adult-participants-with-relapsed-or-refractory-multiple-myeloma-100054075","NCT05650632","A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma","A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Must have measurable disease as outlined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance of \\\u003C= 2. Arm C and Arm D: ECOG performance of \\\u003C= 1.\n* Relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.\n* Must be naïve to treatment with etentamig (ABBV-383).\n* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.\n* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \\[ADC\\] or chimeric antigen receptor T-cell \\[CAR-T\\] directed against BCMA).\n* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n\nExclusion Criteria:\n\n* Arm A: Received BCMA-targeted therapy.\n* Arm C and Arm D: Rapidly progressing disease per investigator.",{"count":157,"type":21},210,[107],"Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed\u002Frefractory (R\u002FR) MM.\n\nEtentamig (ABBV-383) is an investigational drug being developed for the treatment of R\u002FR Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \\& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \\& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed\u002Frefractory multiple myeloma will be enrolled at approximately 50 sites across the world.\n\nParticipants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.",[25],[25,162,163,164],"Cancer","ABBV-383","B-Cell Maturation Antigen","2026-07-09",{"date":37,"type":38},{"date":168,"type":38},"2023-03-21",{"date":170,"type":21},"2029-08",{"name":172,"class":68},"AbbVie",46,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":105,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100484098","phase-1-a-study-evaluating-the-safety-and-efficacy-of-multiple-treatments-in-participants-with-multiple-myeloma-100484098","NCT05583617","A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma","A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma","PLYCOM","Inclusion Criteria:\n\n* Diagnosed with MM per International Myeloma Working Group (IMWG) criteria\n* Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2\n* Resolution of AEs from prior anti-cancer therapy to Grade \\\u003C=1\n* Agreement to undergo scheduled assessments and procedures\n\nAdditional Inclusion Criteria for SS2:\n\n* Completion of planned induction therapy and achievement of at least a partial response (PR)\n* Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease\n* Cytogenetic high-risk features at diagnosis\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest\n* Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception\n* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm\n\nAdditional Inclusion Criteria for SS4:\n\n* Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R\u002FR MM for whom no suitable SOC therapy options are available\n\nExclusion Criteria:\n\n* Inability to comply with protocol-mandated hospitalization and procedures\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of other malignancy within 2 years prior to screening\n* Current or past history of central nervous system (CNS) disease\n* Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event\n* Symptomatic active pulmonary disease or requiring supplemental oxygen\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection\n* Acute or chronic hepatitis C virus (HCV) infection\n* Known history of HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study\n* Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results\n\nAdditional Exclusion Criteria for SS2:\n\n* Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs\n* Harbor lesions at proximity of vital organs that may develop sudden decompensation\u002Fdeterioration in the setting of a tumor flare\n* Prior treatment with any investigational medicinal product, systemic cancer therapy, or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks, whichever is shorter\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment\n* History of erythema multiforme, Grade \\>=3 rash, or blistering following prior treatment with immunomodulatory derivatives\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment Exlcusion Criteria Applicable to SS2 and SS4\n* History of autoimmune disease\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* Received a cumulative dose of corticosteroids equivalent to \\>=140 mg of prednisone within the 14-day period before the first dose of the study drug (does not include pretreatment medication)\n* Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment.\n* Positive and quantifiable EBV PCR or CMV PCR prior to first study treatment\n\nAdditional Exclusion Criteria for SS4:\n\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies within 5 half-lives or 12 weeks before starting pre-phase\n* History of anaphylaxis or hypersensitivity, including \\>=Grade 3 rash, during prior treatment with IMiDs, dexamethasone, any CELMoDs, or the excipients contained in the formulations\n* Known anaphylaxis, allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies (or recombinant antibody-related fusion proteins), or human proteins, CRBN modulating agents or their excipients, or known sensitivity to mammalian-derived products\n* Administration of strong CYP3A modulators; administration of proton-pump inhibitors within 2 weeks of starting study treatment\n* Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment\n* Concurrent administration of a strong inhibitor, modulator or inducer of cytochrome P450 (CYP3A4\u002F5) (including within 14 days of initiating study treatment)\n* History of malignancies, other than MM, unless the subject has been free of the disease for \\>=5 years\n* Peripheral neuropathy \\>Grade 2\n* Prior treatment with cevostamab or another agent targeting FcRH5 or iberdomide\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment\n* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms\n* Treatment with systemic immunosuppressive medications\n* Prior treatment with CAR T-cell therapy (autologous or allogeneic) within 12 weeks before starting pre-phase\n* Autologous SCT within 100 days prior to starting pre-phase\n* Prior allogeneic SCT\n* Plasmacytoma in proximity of vital organs that may develop sudden decompensation\u002Fdeterioration in the setting of a tumor flare",{"count":183,"type":21},200,[107,108],"CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.",[25],"2026-07-01",{"date":189,"type":38},"2026-07-02",{"date":191,"type":38},"2023-11-14",{"date":193,"type":21},"2028-07-31",{"name":195,"class":68},"Hoffmann-La Roche",16,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":105,"phases":207,"briefSummary":208,"conditions":209,"keywords":216,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":46},"100317456","phase-2-administration-of-autologous-t-cells-genetically-engineered-to-express-t-cell-receptors-reactive-against-neoantigens-in-people-with-metastatic-cancer-100317456","NCT03412877","Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer","A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer","* INCLUSION CRITERIA:\n* Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection.\n\nNote: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas.\n\n* Documented diagnosis of cancer.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.\n  * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).\n* Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated.\n* Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant.\n* Participants with three (3) or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child.\n* Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology:\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology:\n\n  * ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry:\n\n  * Serum ALT\u002FAST less than or equal to 5.0 x ULN\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg\u002FdL.\n* Participants must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma.\n\n* For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1\u002FPD-L1, including but not limited to myocarditis and pneumonitis.\n\nNote: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met.\n\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.\n\nNote: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin.\n\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Participants who are receiving any other investigational agents.","72 Years",{"count":206,"type":21},285,[108],"Background:\n\nA person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person.\n\nObjective:\n\nTo see if gene transfer therapy of white blood cells can shrink tumors.\n\nEligibility:\n\nPeople with certain metastatic cancer for which standard treatments have not worked.\n\nDesign:\n\nParticipants may complete screening under another protocol. Screening includes:\n\n* Getting tumor cells from a previous procedure\n* Medical history\n* Physical exam\n* Scans\n* Blood, urine, heart, and lung tests\n\nThe study has 8 stages:\n\n1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm.\n2. Care at home over approximately 12 weeks.\n3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.\n4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs.\n5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart.\n6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.\n7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.\n8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.",[210,211,212,213,214,215,25],"Endocrine Tumors","Non-Small Cell Lung Cancer","Ovarian Cancer","Breast Cancer","Gastrointestinal\u002FGenitourinary Cancers","Neuroendocrine Tumors",[217,218,219,220],"Gene Therapy","Immunotherapy","Cell Therapy","Adoptive Cell Therapy",{"date":189,"type":38},{"date":223,"type":38},"2018-09-06",{"date":225,"type":21},"2029-03-23",{"name":227,"class":228},"National Cancer Institute (NCI)","NIH",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":105,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100614835","phase-2-a-study-to-evaluate-the-efficacy-of-cemsidomide--dexamethasone-in-participants-with-relapsedrefractory-multiple-myeloma-100614835","NCT07284758","A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed\u002FRefractory Multiple Myeloma","A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed\u002FRefractory Multiple Myeloma","MOMENTUM","Inclusion Criteria:\n\n1. Be willing and able to provide signed informed consent for the study.\n2. Age ≥ 18 years at the time of signed consent.\n3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.\n4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1\u002F3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.\n5. Subjects need to have adequate organ function.\n6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.\n7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.\n8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.\n9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.\n10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.\n\nExclusion Criteria:\n\n1. Presence of myeloma in the central nervous system (CNS).\n2. Subjects with any of the following:\n\n   * Systemic light chain amyloidosis\n   * Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome\n   * Myelodysplastic syndrome (MDS).\n3. Previously treated with cemsidomide.\n4. Clinically significant impaired cardiac function or cardiac disease.\n5. Thromboembolic event within 3 months prior to enrollment.\n6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.\n7. Uncontrolled active bacterial, fungal, or viral infection.\n8. Inability or difficulty swallowing tablets.\n\nNOTE: Other inclusion\u002Fexclusion criteria may apply, per protocol.",{"count":238,"type":21},100,[108],"This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed\u002Frefractory multiple myeloma (r\u002Fr MM).",[25,242],"Relapsed\u002FRefractory Multiple Myeloma",[244,245,25],"cemsidomide","dexamethasone","2026-06-30",{"date":187,"type":38},{"date":249,"type":38},"2026-02-18",{"date":251,"type":21},"2030-03",{"name":253,"class":68},"C4 Therapeutics, Inc.",10,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":105,"phases":266,"briefSummary":268,"conditions":269,"keywords":276,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":46},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412","NCT07292272","Halt Aging in Survivors of Blood Cancers","Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study","HALTAging-1","Inclusion Criteria:\n\n1. Age ≥50 years\n2. A history of hematological malignancy\n3. Participants must be able to and willingly give informed consent\n\nExclusion Criteria:\n\n1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.\n2. Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.\n3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.\n4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 \\\u003C10 ml\u002Fkg\u002Fmin).\n5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).\n6. Self-reported pregnancy or the possibility of pregnancy.\n7. Participants who do not plan to follow up at the participating center.","50 Years",{"count":265,"type":21},180,[267],"NA","Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.",[270,84,271,25,272,273,274,275],"Hematological Malignancy","Lymphoid Leukemia","Myeloid Leukemia","Monocytic Leukemia","Non-hodgkin Lymphoma","Other Hematologic Condition",[277,84,271,25,272,273,274,275,278,279,280,281],"Hodgkin Lymphoma","Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","2026-06-29",{"date":187,"type":38},{"date":285,"type":38},"2026-04-09",{"date":287,"type":21},"2033-03-25",{"name":289,"class":45},"University of Nebraska",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":105,"phases":300,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100528290","phase-3-study-assessing-activity-of-intravenous-iv-etentamig-monotherapy-versus-standard-available-therapies-in-adult-participants-with-relapsed-or-refractory-multiple-myeloma-100528290","NCT06158841","Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)","CERVINO","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance of \\\u003C= 2.\n* Diagnosis of relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.\n* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>= 5 g\u002FL).\n  * Urine M-protein \\>= 200 mg\u002F24 hours.\n  * In participants without measurable serum or urine M protein, serum free light chain (FLC) \\>= 100 mg\u002FL (10 mg\u002FdL) (involved light chain)and an abnormal serum kappa lambda ratio.\n* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).\n\n  \\-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.\n* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.\n\nExclusion Criteria:\n\n* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.\n* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.\n* Central nervous system involvement of MM.\n* Has received B-cell maturation antigen (BCMA)-targeted therapy.",{"count":299,"type":21},380,[301],"PHASE3","Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed\u002Frefractory (R\u002FR) MM.\n\nEtentamig is an investigational drug being developed for the treatment of R\u002FR MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and\u002For the institutional guidelines, as applicable. Around 380 adult participants with relapsed\u002Frefractory multiple myeloma will be enrolled at approximately 140 sites across the world.\n\nIn Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and\u002For the institutional guidelines, as applicable, during the 3.5 year study duration.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.",[25],[305,25,306,307,308,309,310,311,312],"Cervino","Etentamig","Carfilzomib","Pomalidomide","Elotuzumab","Selinexor","Bortezomib","Dexamethasone",{"date":246,"type":38},{"date":315,"type":38},"2024-05-19",{"date":317,"type":21},"2027-12",{"name":172,"class":68},166,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":105,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":328,"type":21},492,[301],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[25],[333,164,139,334,335,336,138,337,338,339,340,308,309,311,307,341],"Elranatamab","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","PF-06863135",{"date":187,"type":38},{"date":344,"type":38},"2024-02-08",{"date":346,"type":21},"2027-12-30",{"name":348,"class":68},"Pfizer",271,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":105,"phases":360,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},"100520502","phase-4-elranatamab-post-trial-access-study-for-participants-with-multiple-myeloma-mm-100520502","NCT06057402","Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)","ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES","MagnetisMM15","Inclusion Criteria:\n\n* Participants must agree to follow the reproductive criteria as outlined in the protocol\n* Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.",{"count":359,"type":21},80,[361],"PHASE4","This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.",[25],[25,333,365,366,367,368,356,139,369,370,334,371],"Post Trial Access","Roll-over Study","Extension Study","MM-15","BCMA antibody","Magnetism","Elrexfio",{"date":187,"type":38},{"date":374,"type":38},"2023-10-03",{"date":376,"type":21},"2032-02-22",{"name":348,"class":68},33,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":105,"phases":389,"briefSummary":390,"conditions":391,"keywords":394,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":46},"100524063","phase-2-18f-fluciclovine-petct-in-multiple-myeloma-100524063","NCT06103838","18F-Fluciclovine PET\u002FCT in Multiple Myeloma","A Phase II Trial Evaluating 18F-Fluciclovine PET\u002FCT in Multiple Myeloma","* INCLUSION CRITERIA:\n* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g\u002FdL and\u002For bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\\u003C=10 g\u002FdL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg\u002FdL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg\u002FdL, or\n  * Lytic bone lesions on X-ray, CT, or PET\u002FCT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved\u002Fun-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g\u002Fdl\n  * Urine monoclonal protein \\> 200 mg\u002F24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio\n  * A measurable lesion on PET\u002FCT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and\u002For refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\\u003C= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.","120 Years",{"count":388,"type":21},60,[108],"Background:\n\nMultiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.\n\nObjective:\n\nTo find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.\n\nEligibility:\n\nAdults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).\n\nDesign:\n\nParticipants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET\u002FCT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET\u002FCT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.\n\nAll participants will have a third study visit after 5 years or when their disease progresses.",[25,392,393],"Newly Diagnosed Multiple Myeloma (NDMM)","Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[395,396,397,398,399,400,25],"RRMM","NDMM","18F-FDG PET\u002FCT","PET\u002FCT","18F-fluciclovine","Imaging","2026-06-27",{"date":246,"type":38},{"date":404,"type":38},"2024-03-25",{"date":406,"type":21},"2032-12-06",{"name":227,"class":228},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":105,"phases":418,"briefSummary":419,"conditions":420,"keywords":424,"overallStatus":427,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":46},"100645065","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-hematologic-malignancies-100645065","NCT07679919","BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","A Phase 1 Study of Allogeneic (γ\u002Fδ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","Inclusion Criteria:\n\n1\\. Male or female 18-75 years of age. 2. Patient with:\n\na. NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma\n\nor\n\nb. CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:\n\n1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia. Cutoff levels of Hb \\\u003C10 g\u002FdL or platelet counts \\\u003C100 × 10\\^9\u002FL are generally regarded as indication for treatment.\n2. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n3. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n4. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).\n5. Disease-related symptoms as defined by any of the following:\n\n   1. Unintentional weight loss ≥10% within the previous 6 months.\n   2. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).\n   3. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.\n   4. Night sweats for ≥1 month without evidence of infection.\n\nor\n\nc. HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox.\n\nii. Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) \\\u003C1 × 10\\^3\u002FmcL, Hb \\\u003C10g\u002FdL, platelet count \\\u003C100 × 10\\^3\u002FmcL, leukemia cell count \\>5 × 10\\^3\u002FmcL, symptomatic splenomegaly, or enlarging HCL mass \\>2 cm in short axis.\n\nor\n\nd. MM: histologically confirmed MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\nii. Measurable disease per IMWG uniform response criteria 3. Adequate organ function as defined by:\n\n1. Creatinine clearance more than or equal to 45 ml\u002Fmin calculated by the Cockcroft - Gault formula\n2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.\n3. Adequate pulmonary function with pulse oximetry ≥ 92% on room air.\n4. Total Bilirubin \\\u003C 1.5× the institutional upper limit of normal (\\\u003C2.5× if caused by the baseline cancer and in patients with Gilbert's syndrome).\n5. Alanine aminotransferase (ALT (Serum Glutamic-Pyruvic Transaminase (SGPT))) and Aspartate Aminotransferase (AST (Serum Glutamic-Oxaloacetic Transaminase (SGOT) \\\u003C 2.5× the institutional upper limit of normal.\n\n   4\\. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n\n   5\\. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration\n\nof the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n6\\. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after CAR-T cell infusion to avoid potential embryonal or fetal exposure.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n7\\. Body weight of at least 55kg for patients treated at dose level 3 (450 × million BAFF+ CAR cells) and at least 37kg for all other dose levels.\n\nExclusion Criteria:\n\n1. Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n2. Renal failure requiring regular dialysis.\n3. Uncontrolled pulmonary disease or infection.\n4. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n5. Active infection requiring systemic treatment.\n6. HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies\u002FmL.\n7. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.\n8. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n9. Patients with history of clinically relevant central nervous system (CNS) pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.\n10. Subjects with uncontrolled intercurrent or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Patients receiving a live vaccine within 2 weeks prior to screening.\n12. Concurrent use of high dose systemic steroids and\u002For immunosuppressive therapies.\n\n    1. Steroid dose must be weaned to ≤10 mg\u002Fday prednisone equivalent prior to CAR-T cell infusion.\n    2. Immunosuppressive medications must be stopped at least 5 half-lives prior to CAR-T cell infusion.","75 Years",{"count":417,"type":21},27,[107],"Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory hematologic malignancies, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.",[421,422,423,25],"Non-Hodgkin Lymphoma","Chronic Lymphocytic Leukemia","Hairy Cell Leukemia",[425,426],"Lymphoma","B-cell","NOT_YET_RECRUITING","2026-06-25",{"date":187,"type":38},{"date":431,"type":21},"2026-09",{"date":433,"type":21},"2029-04",{"name":435,"class":68},"Luminary Therapeutics",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":16,"sex":17,"minAge":443,"maxAge":444,"enrollmentInfo":445,"targetDuration":447,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":495,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":511},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals","19 Years","110 Years",{"count":446,"type":21},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,213,84,488,489,490,25,212,491,492,215,493,494],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Melanoma","Sarcoma","Unknown Primary Tumor","Endometrial Cancer","Vaginal Cancer","Plasma Cell Dyscrasia","Healthy Control",[450,451,496,497,498,499,500,501,502,503,213,504,493,494],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":282,"type":38},{"date":507,"type":38},"2013-11-01",{"date":509,"type":21},"2099-12",{"name":289,"class":45},42,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":46},"100635985","a-non-interventional-study-of-melphalan-flufenamide-melflufen-pepaxti-and-dexamethasone-in-patients-with-relapsed-andor-refractory-multiple-myeloma-rrmm-100635985","NCT07559799","A Non-interventional Study of Melphalan Flufenamide (Melflufen) (Pepaxti®) and Dexamethasone in Patients With Relapsed and\u002For Refractory Multiple Myeloma (R\u002FRMM)","MARINA","Inclusion Criteria:\n\n* Patients with R\u002FRMM who have previously been treated with at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who relapsed on or after the last therapy\n* Indication and decision for fourth- or later-line treatment with melflufen (Pepaxti®) and dexamethasone, according to current SmPC as assessed by the treating physician\n* Signed and dated written informed consent\\*.\n* Treatment decision before inclusion into this non-interventional study\n* Age ≥18 years\n\n  * Patients are allowed to be enrolled up to 28 days (+ 14 days) after their first dose of melflufen+dexamethasone,, but before any response assessment and second dose of melflufen+dexamethasone. These patients will not participate in the PRO assessments.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial (except follow-up)\n* Patient unable to consent\n* Contraindications according to current SmPC",{"count":520,"type":21},50,"Multiple myeloma is the second most common hematologic malignancy in adults and despite the new therapies that have been developed in the last decades it remains incurable. Over the course of the disease, patients eventually become refractory to the various treatments. Therefore, new therapeutic options which utilize new mechanisms of action are essential.\n\nMelphalan flufenamide (melflufen) represents such an additional therapeutic approach. Melflufen is a peptide-drug conjugate (PDC) which is highly lipophilic and rapidly incorporated into the tumor cells. Once inside the tumor cell, melflufen is hydrolyzed by peptidases, including aminopeptidases and esterases, to release its alkylator payload. The alkylating agent then induces DNA damage resulting in cell death.\n\nMelphalan flufenamid in combination with Dexamethason was approved by the European Medicines Agency (EMA) in August 2022 for the treatment of patients with triple class refractory relapsed\u002Frefractory Multiple Myeloma who have received at least 3 prior lines of therapy. For patients with prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.\n\nThe non-interventional study MARINA aims to address open scientific questions regarding the effectiveness, as well as therapy and safety management of melflufen in a real-world setting. By collecting comprehensive real-world data - including the Disease Control Rate (DCR) as a key endpoint, which is of most value for patients in this late disease stage - MARINA will investigate the therapeutic benefit of melflufen in routine clinical practice.",[25],"2026-06-24",{"date":525,"type":38},"2026-06-26",{"date":527,"type":38},"2026-06-01",{"date":529,"type":21},"2029-08-30",{"name":67,"class":68},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":105,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":427,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":4},"100639427","phase-2-study-of-alternative-and-approved-dosing-regimens-of-belantamab-mafodotin-bortezomib-and-dexamethasone-bvd-in-participants-with-relapsedrefractory-multiple-myeloma-100639427","NCT07614360","Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed\u002FRefractory Multiple Myeloma","A Phase 2, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Alternative and Approved Dosing Regimens of Belantamab Mafodotin in Combination With Bortezomib and Dexamethasone (BVd) in Participants With Relapsed\u002FRefractory Multiple Myeloma","DREAMM-16","Inclusion Criteria:\n\n* Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by the IMWG.\n* Previously treated with at least 2 prior lines of MM therapy, including a proteasome inhibitor and an immunomodulatory agent.\n* Has at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as at least 1 of the following:\n\n  * Urine M-protein excretion \\>=200 milligrams (mg)\u002F24 hours (\\>=0.2 grams \\[g\\]\u002F24 hours)\n  * Serum M-protein concentration \\>=0.5 grams per deciliter (g\u002FdL) (\\>=5.0 g\u002FL)\n  * Serum free light chain (FLC) assay: involved FLC level \\>=10 milligrams per deciliter (mg\u002FdL) (\\>=100 mg\u002FL) and an abnormal serum FLC ratio (less than \\[\\\u003C\\] 0.26 or greater than \\[\\>\\] 1.65).\n* Participants with a history of autologous stem cell transplants are eligible for study participation provided the following eligibility criteria are met:\n\n  * Transplant was \\> 100 days prior to study enrollment\n  * No active infection(s)\n  * Participant meets the remainder of the eligibility criteria\n* All prior treatment-related toxicities (defined by NCI-CTCAE version \\[v\\] 6.0) must be Grade less than or equal to (\\\u003C=)1 at the time of treatment assignment, except for alopecia (any grade), neuropathy (Grade \\\u003C=2), or endocrinopathy managed with replacement therapy (any grade).\n* Is willing to use adequate contraception male and female participants. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  1. Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of belantamab mafodotin and 5 months after the last dose of bortezomib, whichever is longest, to allow for clearance of any altered sperm:\n\n     * Refrain from donating fresh unwashed semen PLUS either\n     * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), including any activity or passage of ejaculate to another person, and agree to remain abstinent. OR\n     * Must agree to use contraception\u002Fbarrier as detailed below:\n\n     Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1 percent (%) per year when having sexual intercourse with a partner who can become pregnant and is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females\n  2. Female participants are eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n\n     * Is a Person of non-childbearing potential (PONCBP) OR\n     * Is a Person of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, during the study intervention period and for at 4 months after the last dose of belantamab mafodotin or 8 months after the last dose of bortezomib, whichever is longest, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n     * A POCBP must have a negative highly sensitive serum pregnancy tests within 72 hours before the first dose of study intervention.\n     * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a person with an early undetected pregnancy.\n* Is capable of giving signed informed consent.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Has adequate organ system functions as defined by the laboratory assessments.\n* Participants with a history of Hepatitis B virus (HBV) and\u002For Hepatitis C virus (HCV) and Human immunodeficiency virus (HIV) exposure are eligible under specific conditions.\n\nExclusion Criteria:\n\n* Intolerant to bortezomib\n* Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \\>5%)\n* Has previous or concurrent invasive malignancy other than Multiple myeloma (MM), except:\n\nThe disease must be considered medically stable for at least 2 years; or\n\n* The participant must not be receiving active therapy, other than hormonal therapy for this disease.\n\n  * Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n  * Evidence of active mucosal or internal bleeding.\n  * Active infection requiring treatment\n  * Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with Medical Monitor.\n  * Active or history of venous and arterial thromboembolism within the past 3 months.\n  * Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.\n  * Current corneal epithelial disease except for mild punctate keratopathy\n  * Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n  * Participants after prior allogeneic stem cell transplant.\n  * Has received prior belantamab mafodotin therapy.\n  * Has received treatment with an investigational agent within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody and any other B-cell maturation antigen (BCMA) targeting-therapy. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 mg\u002Fday for a maximum of 4 days) before treatment.\n  * Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n  * Plasmapheresis within 7 days prior to the first dose of study treatment. Screening laboratory values must be performed after last plasmapheresis\n  * Has received any live vaccine within 30 days of randomization\u002Fenrollment. Vaccination against Coronavirus Disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.\n  * Is currently enrolled or has participated in any other clinical study involving an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of study intervention.\n  * Known Human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n* Established anti-retroviral therapy for at least 4 weeks and HIV viral; load \\\u003C400 copies\u002Fmilliliter (mL)\n* Cluster of differentiation 4 (CD4+) T-cell counts \\>=350 cells\u002Fmicroliter;\n* No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.\n\n  * Is pregnant, plan to become pregnant, or breastfeeding.\n  * Has an Alanine aminotransferase (ALT) value \\>2.5 times Upper limit of normal (ULN).\n  * Has a total bilirubin value \\>1.5 times ULN\n  * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.\n  * Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention unless HCV Ribonucleic acid (RNA) is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.\n  * Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.\n  * Has documented presence of Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B virus antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention unless specific criteria are met.\n  * Evidence of cardiovascular risk including any of the following:\n* Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular block.\n* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Uncontrolled hypertension • Has QT interval corrected (QTc) \\>450 milliseconds (msec) or QTc \\>480 msec for participants with bundle branch block.",{"count":540,"type":21},150,[108],"The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.",[25],[545,311,546,312,537,547,548],"Belantamab mafodotin","Corneal events","Proteasome inhibitor","Immunomodulatory agent",{"date":523,"type":38},{"date":551,"type":21},"2026-08-03",{"date":553,"type":21},"2031-02-11",{"name":555,"class":68},"GlaxoSmithKline",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":105,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":575},"100524362","phase-2-iberdomide-and-daratumumab-as-maintenance-therapy-after-an-autologous-stem-cell-transplant-for-multiple-myeloma-100524362","NCT06107738","Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma","IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Therapy in Multiple Myeloma","IBEX","Inclusion Criteria:\n\n1. Multiple Myeloma patients who have received prior DARA-containing induction therapy and have attained at least a partial response.\n2. Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without post-ASCT disease progression (according to IMWG criteria)\n3. Patients who are Minimal Residual Disease positive (MRD (+)) as measured by the ClonoSEQ assay using a sensitivity of 10-5, measured 90-150 days following ASCT.\n4. Prior DARA-containing induction therapy (at least 3 cycles), attaining at least a partial response.\n5. Completed ASCT within 90-150 days prior to registration, without any post-ASCT therapy and without evidence of post-ASCT disease progression (according to IMWG criteria)\n6. MRD (+) at the time of study enrollment using the clonoSEQ NGS (next-generation sequencing) assay. Patients with an M-spike of ≥ 0.5 g\u002FdL and\u002For an abnormal free light chain ratio (with an involved serum free light chain of ≥ 10 mg\u002FdL) at enrollment are considered MRD (+) and do not require baseline MRD testing if they have previously had this testing done with successful clonality assessment.\n7. ECOG (Eastern Cooperative Oncology Group) Performance Status \\\u003C\u002F= 2\n8. Adequate bone marrow function as evidenced by platelets \\>\u002F= 75,000\u002Fmm3, hemoglobin \\>\u002F= 8 g\u002FdL, and ANC (absolute neutrophil count) \\>\u002F= 1,000\u002Fmm3 within 28 days prior to registration. NOTE: transfusion to achieve the hemoglobin threshold IS permissible.\n9. Adequate hepatic function defined by the following within 28 days prior to registration: total bilirubin \\\u003C\u002F=1.5 x IULN (institutional upper limit of the norm, except in case of Gilbert's syndrome) AND AST (aspartate aminotransferase and ALT (aspartate transaminase) \\\u003C\u002F=3.0 x IULN\n10. Adequate renal function, as defined by creatinine clearance (CrCl) \\>\u002F= 30 mL\u002Fmin., as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 28 days prior to registration.\n11. All ASCT-related toxicities must have recovered to \\\u003C\u002F=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to registration\n12. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU (milli-International unit)\u002FmL within 10-14 days prior to registration. FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 7 days before starting IBER, during therapy, during dose interruptions and continuing for 28 days following discontinuation of Iberdomide and for 90 days following the discontinuation of daratumumab. FCBP must also agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 28 days after the last dose of iberdomide and for 90 days after the last dose of daratumumab. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed.\n13. Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 90 days after the last dose of study treatment. They must also agree to not donate sperm during the study and for 90 days after either the last dose of iberdomide or the last dose of daratumumab.\n14. Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n15. Age 18 yrs. old or greater\n\nExclusion Criteria:\n\n1. Active HIV, or HCV (defined as detectable viremia for any of these conditions).\n2. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen\\[HBsAg\\]). Patients with resolved infection (i.e., patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time PCR (polymerase chain reaction) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.\n\n   EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n3. Unable to assess MRD status at entry or is MRD(-) at 10-5 threshold at entry\n4. Heart attack or stroke within 90 days of study enrollment\n5. Unable to tolerate required anti-thrombotic or anti-viral prophylaxis\n6. Major surgery within 28 days of enrollment\n7. Medical, neurologic, or psychiatric condition which renders patient unable to safely comply with study therapy and schedule requirements (including, but not limited to, unstable angina, New York Heart Association Class III-IV congestive heart failure, or uncontrolled cardiac arrhythmia)\n8. Intolerance of prior DARA therapy (requiring discontinuation of DARA previously due to toxicity)\n9. A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years.\n10. Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma.\n11. Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal.\n12. Have known moderate or severe persistent asthma within the past 2 years (see Section 9.2.4), or current uncontrolled asthma of any classification. Note that patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study, provided that FEV1 is ≥50% of predicted normal.\n\n    Note: pursuant to exclusion criteria (k) and (l), FEV1 testing is required for patients with suspected COPD or asthma. Patients with FEV1 \\\u003C50% of predicted normal (or for patients ≥65 years of age, old FEV1 \\\u003C50% or diffusing capacity of the lung \\[DLCO\\] \\\u003C50%) on screening assessment must be excluded.\n13. Have any of the following:\n\n    1. Myocardial infarction within 6 months of enrollment, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV),\n    2. Uncontrolled cardiac arrhythmia\n14. Have known allergies, hypersensitivity, or intolerance to boron or mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the IB) or known sensitivity to lenalidomide, thalidomide, or pomalidomide.\n15. Be pregnant, or breast-feeding, or planning to become pregnant or breast-feed while enrolled in this study or within 90 days after the last dose of study treatment(s). Or, if male, planning to father a child while enrolled in this study or within 90 days after the last dose of study treatment(s).\n16. Prolongation of QT interval on screening ECG as defined by a QTc interval \\> 470 msec using Fridericia's QT correction formula.\n17. Use of strong inhibitors or inducers of CYP3A4, P-gp, or BCRP for at least 14 days or 5 half-lives (whichever is shorter) prior to initiating protocol therapy.",{"count":388,"type":21},[108],"The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant \\[ASCT\\]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. The main questions it aims to answer are:\n\n* Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an effective treatment and warrants further investigation in patients with residual disease\n* Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option\n\nParticipants will:\n\n* provide informed consent and complete screening assessments for eligibility within 28 days of starting treatment\n* Screening assessments include specific laboratory tests, a medical history assessment and a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), an assessment of your heart function, a breathing test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD) and a questionnaire\n* If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of 26 cycles or progressive disease, whichever is first)\n* while receiving treatment on study, physical exams (including temperature, pulse, blood pressure, respirations, height and weight), toxicity assessments, laboratory assessments and questionnaires will be done at various times over the course of the 26 cycles\n* an MRD assessment is required at 6, 12 and 24 months after starting treatment\n* End of treatment will occur once 26 cycles are completed, or cancer has progressed whichever comes first. At that time, specific laboratory tests, a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing (MRD) will occur.",[25],{"date":525,"type":38},{"date":570,"type":38},"2023-12-21",{"date":572,"type":21},"2028-12-31",{"name":574,"class":45},"Barbara Ann Karmanos Cancer Institute",2,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":105,"phases":585,"briefSummary":586,"conditions":587,"keywords":613,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":46},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":78,"type":21},[108],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[588,589,590,425,591,592,593,594,595,596,597,422,598,599,600,601,602,603,604,605,606,607,25,608,609,610,611,612],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[614,17,615,616,617,618,619],"AML","MDS","NHL","CLL","CML","SLL",{"date":428,"type":38},{"date":622,"type":38},"2018-03-30",{"date":624,"type":21},"2028-06-10",{"name":626,"class":45},"Masonic Cancer Center, University of Minnesota",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":386,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":635,"conditions":636,"keywords":640,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":46},"100261446","biospecimen-procurement-for-center-for-immuno-oncology-immunotherapy-protocols-100261446","NCT02682667","Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols","* INCLUSION CRITERIA:\n\n  1. Diagnosis of cancer, a premalignant\u002Fneoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant\u002Fneoplastic condition\n  2. Age \\>=18 years of age\n  3. ECOG performance status of 0-3.\n\n  5\\. Ability and willingness of subject to provide informed consent\n\nAdditional inclusion criteria pertinent only for participants undergoing apheresis\n\n1. Hemoglobin \\>= 8 mg\u002FdL and platelet count \\> 75 K\u002FmicroL\n2. Weight \\>= 48 kg\n3. Central line in place or adequate venous access\n\nEXCLUSION CRITERIA:\n\n1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.\n2. Inability to provide informed consent\n3. Pregnant or breastfeeding women",{"count":634,"type":21},500,"Background:\n\nCancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.\n\nObjective:\n\nTo better understand the biology of malignancies and why certain cancers respond differently to treatment.\n\nEligibility:\n\nAdults at least 18 years old with cancer or a pre-cancerous condition.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.\n\nParticipants will send tissue blocks or slides from their original tumor biopsy.\n\nAt least once, participants will have a medical history, physical exam, and blood and urine tests.\n\nParticipants may have the following tests. They may have them more than once:\n\nApheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.\n\nBone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.\n\nPiece of cancer tissue taken by a needle and syringe.\n\nComputed tomography (CT) scan, magnetic resonance imaging (MRI) and\u002For positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.\n\nA small piece of skin removed.\n\nParticipants will be contacted by phone once a year to find out how they are doing.",[25,637,638,639,211],"Lymphoma, Non-Hodgkin","Leukemia-Lymphoma, Adult T-Cell","Hodgkin Disease",[641,642,643,644,645,646],"Apheresis Products","Immunological","Diverse Malignan","Premalignant","Protein","Natural History",{"date":523,"type":38},{"date":649,"type":38},"2016-04-11",{"date":651,"type":21},"2032-12-01",{"name":227,"class":228},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":661,"enrollmentInfo":662,"targetDuration":4,"studyType":105,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":427,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":670,"leadSponsor":672,"locationsCount":4},"100644525","phase-3-gmmg-hd11dsmm-xxi64007957mmy3010-100644525","NCT07671287","GMMG-HD11\u002FDSMM XXI\u002F64007957MMY3010","Accelerate Improvement in Multiple Myeloma for Newly Diagnosed Transplant-Eligible Patients","AugMMent","Inclusion Criteria:\n\n1. 18 to 70 years of age, inclusive.\n2. Documented MM as defined by the criteria below:\n\n   1. MM diagnosis according to IMWG diagnostic criteria (Appendix 3),\n   2. Untreated MM requiring systemic therapy,\n   3. Measurable disease at screening, as defined by any of the following:\n\n   i. Serum M-protein level ≥1.0 g\u002FdL (central laboratory); or ii. Urine M-protein level ≥200 mg\u002F24 hours (central laboratory); or iii. Serum immunoglobulin free light chain ≥10 mg\u002FdL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n3. Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment.\n4. Have clinical laboratory values meeting the following criteria during the screening period. Refer to Section 5.4.3 for criteria prior to first dose.\n\n   Hemoglobin ≥7.5 g\u002FdL (≥4.65 mmol\u002FL; without prior RBC transfusion ≤7 days before the screening laboratory test; recombinant human erythropoietin use is permitted). Platelets ≥75×109\u002FL in participants in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥50×109\u002FL in participants in whom ≥50% of bone marrow nucleated cells are plasma cells. Absolute neutrophil count ≥1.0×109\u002FL (prior growth factor support is permitted but must be without support for ≥7 days for G-CSF or GM-CSF and ≥14 days for pegylated-G-CSF) before the screening laboratory test.\n\n   Chemistry:\n\n   AST and ALT ≤3×ULN. Total bilirubin Total bilirubin ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case if total bilirubin is \\>2.0×ULN, then direct bilirubin ≤1.5×ULN is required).\n\n   eGFR ≥30 mL\u002Fmin based on Cockcroft-Gault formula or creatine clearance measured by a 24-h urine collection. Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL; see Appendix 10).\n5. Eligible for HD melphalan and ASCT (in the opinion of the investigator).\n6. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n7. A female participant must be (as defined in Appendix 1):\n\n   1. Not of childbearing potential, or\n   2. Of childbearing potential and practicing at least 1 highly effective method of contraception\n8. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment because anticancer treatments may impair fertility.\n9. A male participant must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anticancer treatments may impair fertility.\n11. Must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy.\n12. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n13. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol\n\nExclusion Criteria:\n\n1. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM).\n2. Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy.\n3. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n   1. Nonmuscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, \\\u003C3 cm, no carcinoma in situ).\n   2. Nonmelanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.\n   3. Noninvasive cervical cancer.\n   4. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (antihormonal therapy is permitted).\n   5. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy\u002Fradiation therapy\u002Ffocal treatment).\n   6. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor's medical monitor.\n4. Plasma cell leukemia (presence of ≥5% circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic MM; Fernández de Larrea 2021), smoldering MM, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), primary light chain amyloidosis.\n5. CNS involvement or clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required to exclude CNS involvement.\n6. Prior BCMA-directed therapy.\n7. Prior T-cell redirection therapy.\n8. History of allogeneic or autologous stem cell transplant or prior organ transplant.\n9. Prior or concurrent exposure to any of the following within the specified timeframe prior to randomization:\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.\n   2. Investigational vaccine within 4 weeks.\n   3. Monoclonal antibody therapy within 21 days.\n   4. Radiotherapy within 14 days or focal radiation within 7 days.\n10. Received a cumulative dose of corticosteroids equivalent to dexamethasone ≥160 mg within 14 days before treatment randomization (see Appendix 7).\n11. Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment. Nonlive or nonreplicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed.\n12. Participant had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.\n13. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, ie, those listed below, or any others that in the opinion of the investigator would constitute a hazard for participating in the study.\n\n    1. Acute diffuse infiltrative pulmonary disease.\n    2. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy.\n    3. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed.\n    4. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status.\n    5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the study site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n    6. History of noncompliance with recommended medical treatments.\n14. Stroke, transient ischemic attack, or seizure within 6 months prior to randomization.\n15. Any of the following:\n\n    1. Seropositive for human immunodeficiency virus (HIV).\n    2. Hepatitis B infection (ie, positive HBsAg or detectable HBV DNA levels by RTPCR).\n\n       In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status see Section 6.8.2.8 for further required assessments.\n    3. Active hepatitis C infection as measured by detectable HCV RNA. Participants with a history of HCV antibody positivity must undergo HCV RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n    4. COPD with a FEV1 \\\u003C50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or asthma and participants must be excluded if FEV1 \\\u003C50% of predicted normal.\n    5. Moderate or severe persistent asthma within the past 2 years (see Appendix 8), or uncontrolled asthma of any classification. Note that FEV1 testing is required for participants known or suspected asthma and participants must be excluded if FEV1 \\\u003C50% of predicted normal.\n16. Presence of the following cardiac conditions:\n\n    1. New York Heart Association stage III or IV congestive heart failure (Appendix 12).\n    2. Myocardial infarction, unstable angina, or coronary artery bypass graft\n\n       ≤6 months prior to enrollment.\n    3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n    4. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.\n17. Participant is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.\n18. Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment.\n19. History of hypersensitivity to study intervention or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.\n20. Participation in other clinical studies or observation period of competing clinical studies, respectively.\n21. Held in an institution by legal or official order.\n22. Legally incapacitated.","70 Years",{"count":663,"type":21},399,[301],"This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen.\n\nA total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included.\n\nThe primary objective of the clinical trial:\n\nTo determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction\u002Fconsolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM.\n\nEndpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.",[25],"2026-06-22",{"date":525,"type":38},{"date":246,"type":21},{"date":671,"type":21},"2033-01-30",{"name":673,"class":45},"University of Heidelberg Medical Center",{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":680,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":682,"targetDuration":4,"studyType":105,"phases":684,"briefSummary":685,"conditions":686,"keywords":689,"overallStatus":427,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":699},"100611939","phase-2-eldorado-elranatamab-versus-daratumumab-in-combination-with-rvd-lite-for-newly-diagnosed-transplant-ineligibledeferred-multiple-myeloma-100611939","NCT07247097","ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Newly diagnosed multiple myeloma, with monoclonal plasma cells in the bone marrow ≥10% or a biopsy proven plasmacytoma and either CRAB criteria or biomarker of malignancy\n\n  a. CRAB criteria, one or more of the following: i. Hypercalcemia: serum calcium (\\>1 mg\u002FdL) higher than the upper limit of normal or \\>11 mg\u002FdL ii. Renal insufficiency: creatinine clearance \\\u003C40 mL\u002Fmin (calculated per local practice) or serum creatinine \\>2 mg\u002FdL iii. Anemia: hemoglobin value \\>2 g\u002FdL below the lower limit of normal or hemoglobin \\\u003C10 g\u002FdL iv. Bone lesions: one or more lytic lesions on skeletal radiography, CT, or PET CT b. Biomarker of malignancy (one or more of the following): i. Clonal bone marrow plasma cells ≥60% ii. Involved:uninvolved serum free light chain ratio ≥100 iii. \\>1 focal lesion on magnetic resonance imaging (MRI)\n* Measurable disease as defined by one of the following:\n\n  1. Serum monoclonal protein ≥0.5 g\u002FdL. For IgA monoclonal protein, total IgA \\>500 mg\u002FdL is allowable.\n  2. Urine monoclonal protein ≥200 mg\u002F24 hours\n  3. Involved serum free light chain ≥100 mg\u002FL with abnormal free light chain ratio\n* Not considered eligible for high dose melphalan and autologous stem cell transplant per treating investigator or plan for deferred high dose melphalan and autologous stem transplant\n* ECOG performance status of 0-2\n* ANC ≥1000\u002FμL. G-CSF is not permitted within 14 days of screening.\n* Platelet count ≥75,000\u002FµL. Platelet count ≥50,000\u002FµL is permitted if bone marrow is \\>50% involved. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin, not requiring dialysis, with calculation per local practice.\n* Serum bilirubin values \\\u003C 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.\n* Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent.\n* Females of childbearing potential (FCBP) must:\n\n  1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy within 10-14 days, with the second test within 24 hours of starting lenalidomide. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.\n  2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.\n* Male subjects must follow the lenalidomide REMS.\n* Ability and the willingness to undergo repeat bone marrow biopsy assessments.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior or current systemic therapy for any plasma cell disorder. An exception is emergency use of corticosteroids (equivalent to dexamethasone 40 mg daily for four days). After discussion with the principal investigator. one cycle of standard of care myeloma therapy (without anti-CD38 monoclonal antibody) is permissible to allow for stabilization of disease, during screening\u002Fprior to enrollment.\n* Pregnancy, currently breastfeeding, or planned breastfeeding.\n* Participant plans to father a child while enrolled in the study or within 100 days after last dose of study treatment.\n* Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥3 years. Patients who are free of disease \\\u003C3 years may enroll after approval of the PI (e.g. localized breast cancer considered to have very low risk of recurrence). Exceptions include the following (i.e. the following are eligible to participate):\n\n  1. Basal or squamous cell carcinoma of the skin\n  2. Carcinoma in situ of the cervix\n  3. Ductal carcinoma in situ of the breast\n  4. Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance\n  5. Other malignancies of clinically localized disease may be permitted to enroll after discussion with the Sponsor-Investigator\n* Patients with plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.\n* Seropositive for HIV infection.\n* Hepatitis B viral load positive.\n* Hepatitis C viral load positive.\n* Peripheral neuropathy ≥grade 2.\n* Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:\n\n  1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n  2. Unstable angina\n  3. Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block\n  4. Recent (within the preceding 6 months) myocardial infarction or stroke\n  5. Severe non-ischemic cardiomyopathy.\n  6. Uncontrolled hypertension\n  7. Diabetes mellitus with \\>2 episodes of ketoacidosis in the preceding 12 months\n  8. Chronic obstructive pulmonary disease (COPD) requiring \\>2 hospitalizations in the preceding 12 months.\n  9. Acute diffuse infiltrative pulmonary disease.\n  10. Active bacterial, viral, or fungal infection\n  11. Stroke, transient ischemic attack, or seizure within six months of starting treatment.\n* Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.\n* Major surgery within 4 weeks prior to C1D1. Kyphoplasty or vertebroplasty are not considered major surgery.\n* Received an investigational drug (or vaccine) or used an invasive investigational medical device within four weeks before screening or is currently enrolled in an interventional investigational study.\n* Live or live-attenuated vaccine within 30 days prior to C1D1.",{"count":683,"type":21},160,[108],"This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible\u002Fdeferred multiple myeloma.",[25,687,688,392],"Newly Diagnosed Multiple Myeloma","Transplant Ineligible",[396,31,680,690,691],"RVd lite","transplant ineligible\u002Fdeferred",{"date":92,"type":38},{"date":694,"type":21},"2026-08-01",{"date":696,"type":21},"2035-12-01",{"name":698,"class":45},"Massachusetts General Hospital",3,{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":4,"eligibilityCriteria":706,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":707,"targetDuration":4,"studyType":105,"phases":709,"briefSummary":710,"conditions":711,"keywords":712,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":716,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":722},"100589403","phase-1-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-oral-surzetoclax-alone-or-in-combination-with-subcutaneous-andor-oral-antimyeloma-agents-in-adult-participants-with-multiple-myeloma-mm-100589403","NCT06953960","A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and\u002For Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)","A Phase 1\u002F2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n* Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.\n* All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>= 5g\u002FL); OR\n  * Urine M-protein \\>= 200 mg\u002F24 hours; OR\n  * For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg\u002FdL (100 mg\u002FL), provided sFLC ratio is abnormal.\n* B-cell lymphoma (BCL)-2 inhibitor treatment naïve.\n* t(11;14) positive status and\u002For BCL2 high status.\n* Substudy 1 Dose Escalation Cohorts and Substudy 2:\n\n  \\-- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator.\n* Substudy 1 Dose Expansion Cohorts:\n\n  * Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks of study treatment or planned during study participation.\n* Active infections: no recent infection requiring systemic treatment that was completed \\\u003C= 7 days before first dose of study treatment and\u002For uncontrolled systemic infection.\n* Recent infection requiring systemic treatment that was completed \\\u003C= 7 days before first dose of study treatment and\u002For uncontrolled active systemic infection.",{"count":708,"type":21},199,[107,108],"Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed\u002Frefractory (R\u002FR) MM. Adverse events and change in disease activity will be assessed.\n\nSurzetoclax is an investigational drug being developed for the treatment of R\u002FR MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of surzetoclax in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. Approximately 130 adult participants with R\u002FR MM will be enrolled in the study in approximately 40 sites worldwide.\n\nIn Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. The total study duration is approximately 4.5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.",[25],[25,713,714,715,312,308,162],"ABBV-453","Surzetoclax","Daratumumab",{"date":523,"type":38},{"date":718,"type":38},"2025-07-23",{"date":720,"type":21},"2030-12",{"name":172,"class":68},47,{"id":724,"slug":725,"hasResults":12,"nctId":726,"briefTitle":727,"officialTitle":728,"acronym":729,"eligibilityCriteria":730,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":731,"targetDuration":4,"studyType":105,"phases":733,"briefSummary":734,"conditions":735,"keywords":736,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":738,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":744},"100487126","phase-3-a-study-to-learn-about-the-effects-of-the-combination-of-elranatamab-daratumumab-and-lenalidomide-compared-with-daratumumab-bortezomib-lenalidomide-and-dexamethasone-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-not-candidates-for-transplant-100487126","NCT05623020","A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant","AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA","MagnetisMM-6","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)\n* Measurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n  * Serum M-protein ≥0.5 g\u002FdL (Part 1) and ≥1 g\u002FdL (Part 2);\n  * Urinary M-protein excretion ≥200 mg\u002F24 hours;\n  * Involved FLC ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Part 1: Participants with relapsed\u002Frefractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \\\u003C65 years with comorbidities impacting the possibility of transplant.\n* Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:\n\n  * Participants not considered candidates for high-dose chemotherapy and ASCT due to age or\n  * Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.\n* ECOG performance status ≤2.\n* Not pregnant and willing to use contraception\n* For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.\n\nExclusion Criteria:\n\n* Smoldering Multiple Myeloma.\n* Monoclonal gammopathy of undetermined significance.\n* Waldenströms Macroglobulinemia\n* Plasma cell leukemia.\n* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19\u002FSARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0\u002F1 with minimal risk of recurrence per investigator.\n* For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.\n* For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.\n* Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.\n* Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.",{"count":732,"type":21},1116,[301],"Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.\n\nThere are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.",[25],[333,341,164,715,737,138,729,311],"Lenalidomide",{"date":92,"type":38},{"date":740,"type":38},"2022-11-10",{"date":742,"type":21},"2033-10-03",{"name":348,"class":68},121]